Autism Spectrum DisorderPhase 2ION-ASDNCT02918864

Oxytocin and Social Cognitive Skills Groups

A Phase 2 study testing Oxytocin, Social Cognitive Skills Training and Facilitated Play Therapy in people with Autism Spectrum Disorder, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the feasibility, safety, and preliminary efficacy of integrating targeted dosing of intranasal oxytocin with a social cognitive skills group therapy for school-aged children with autism spectrum disorder (ASD). Read more about this study

Who is it for?: Ages 8 to 11 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: Oxytocin, Social Cognitive Skills Training and Facilitated Play Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 15 Jun 2016to Sep 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female outpatients, 8-11 years of age inclusive
Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for Autism Spectrum Disorder. DSM-V criteria will be established by a clinician with expertise with individuals with ASD. Best estimate Diagnosis will be reached using DSM-5 criteria, the Autism Diagnostic Observation Schedule (ADOS-2) and the Autism Diagnostic Interview (ADI-R), or Autism Screening Interview.
Mean score of 9 or less on mentalizing items of Strange Stories Test (Highest possible score = 12, items 21-25, 27).
Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Baseline.
Verbal and performance scale intelligence quotient (IQ) ≥ 80 (both subtests of the Wechsler Intelligence Scale for Children-V (WISC-V) ≥ 70).
If already receiving stable concomitant medications, have continuous participation during the preceding 30 days prior to Screening, and not electively initiate new or modify ongoing medications for the duration of the study. For serotonergic agents, 6 months on a stable dose is required.

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If already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening, and not electively initiate new or modify ongoing interventions for the duration of the study.
Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed not clinically significant by the Treating Clinician.
Ability to speak and understand English sufficiently to allow for the completion of all study assessments.
Ability to obtain written assent from the participant as well as written informed consent from their parent(s)/legal guardian.

Who cannot join

Patients born prior to 35 weeks gestational age.
Patients with a primary psychiatric diagnosis other than ASD.
Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal brain MRI/structural lesion.
Pregnant female patients, sexually active female patients on hormonal birth control and sexually active females who do not use at least two types of non-hormonal birth control.
Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease.
Patients with one or more of the following: hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder or severe depression.

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Patients who are currently taking oxytocin (OXT) or have taken intranasal oxytocin (IN-OXT) in the past with no response.
Patients who have an Aberrant Behavior Checklist (ABC) Irritability subscale score > 19 at screening
Patients with sensitivity to OXT or any components of its formulation.
Patients unable to tolerate venipuncture procedures for blood sampling.
Patients in foster care for whom the state is defined as a legal guardian.
If they have an arrhythmia present on ECG, that upon consultation with a cardiologist, is deemed to be clinically significant.
Patients with any of the following clinical lab results
Alanine transaminase (ALT) or aspartate transaminase (AST) levels of ≥ 5 times the upper limit of normal, or if clinical jaundice occurs
Sodium levels of > 152 mmol/L or < 128 mmol/L
Potassium levels of > 6 mmol/L in a non-hemolyzed sample
Glucose levels of > 11 mmol/L or < 2.8 mmol/L
Hemoglobin levels of < 100 g/L
Blood urea nitrogen (BUN) levels of > 100 mmol/L
Creatinine levels of > 100 µmol/L
Osmolality levels of > 330 mmol/kg

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Integrated Oxytocin and Nonverbal, Emotion Recognition, and Theory of Mind Training for Children With Autism Spectrum Disorder

Read the detailed description

The study is a proof-of-concept, combination intervention designed to address individual treatment targets presumed to influence social learning in school-aged children with autism spectrum disorder (ASD). This proposal builds upon prior research on an empirically supported social cognitive skills training curriculum, NETT (Nonverbal communication, Emotion recognition, and Theory of mind Training). NETT is a cognitive-behavioral intervention (CBI) for nonverbal communication, emotion recognition, and theory of mind deficits in youth with ASD. In this two-phase, 3 year, single-blind, contact controlled study, school-aged children with ASD (n=60) will be randomized into a 12-session, parallel group design of Integrated Oxytocin and NETT (ION) or a control social group condition (facilitated play). The study aims to evaluate the safety, tolerability, and efficacy of integrating the neuropeptide, oxytocin (OXT), with the social cognitive curriculum, as well as to identify targets of change and pre-treatment factors predictive of response to ION-ASD. Maintenance of treatment effects will also be assessed 1 month and 3 months post-treatment.

Conditions: Autism Spectrum Disorder
Being tested: Oxytocin, Social Cognitive Skills Training, Facilitated Play Therapy
Keywords: Autism Spectrum Disorder, Oxytocin, Social Skills, Social cognitive skills, Cognitive Behavioral Intervention, Combination treatment, Syntocinon, NETT (Nonverbal communication, Emotion recognition, Theory of mind Training), emotion recognition, theory of mind
Medical subject headings: Autism Spectrum Disorder, Social Skills, Nonverbal Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxytocinDrug
Also called Syntocinon
This is an integrated pharmacological-behavioral intervention targeting social cognitive skills for school-aged children with ASD. Four doses of intranasal oxytocin (24 IUs/dose) will be delivered each week before weekly homework and group therapy sessions.
Social Cognitive Skills TrainingBehavioural
Also called NETT
Social cognitive skills training utilize cognitive behavioral strategies such as problem identification, affective education, performance feedback, and weekly homework activities to target impairments in nonverbal synchrony, emotional expression, and interpretation of intent. The NETT curriculum is manualized and anchored in CBI strategies, such as problem identification, affective education, performance feedback, and weekly homework activities. Parent education sessions run concurrently with child groups to help facilitate generalization.
Facilitated Play TherapyBehavioural
The facilitated play therapy group is a manualized treatment designed to tailor play to the interests and abilities of group members. Therapists use general therapeutics strategies such as reflective functioning statements to foster communication with therapists as well as between peers. Standard educational practices for children with ASD such as visual supports, schedules, and short-directed statements are also used. The concurrent parent group is supportive in nature.

Study groups in NCT02918864
Study group	Role	What they receive
ION-ASD	Experimental	ION-ASD integrates targeted dosing of intranasal oxytocin and social cognitive skills group training curriculum, Seaver-NETT (Nonverbal communication, Emotion recognition, Theory of mind Training). Receives: Drug: Oxytocin; Behavioral: Social Cognitive Skills Training
Facilitated Play	Active comparator	The active comparison condition is a facilitated play therapy group. Receives: Behavioral: Facilitated Play Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Social Behavior Impairment (SBI) Composite
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Measured: Baseline and Week 12 (Endpoint)
Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Measured: Baseline and Week 12 (Endpoint)
Change From Baseline in Social Behavior Impairment (SBI) Composite
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Measured: Baseline and Week 16 (1-month follow-up)
Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Measured: Baseline and Week 16 (1-month follow-up)
Change From Baseline in Social Behavior Impairment (SBI) Composite
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Measured: Baseline and Week 24 (3-month follow-up)
Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Measured: Baseline and Week 24 (3-month follow-up)
Change From Baseline in Social Cognition (SC) Composite
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Measured: Baseline and Week 12 (Endpoint)
Rate of Change From Baseline in Social Cognition (SC) Composite
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Measured: Baseline and Week 12 (Endpoint)
Change From Baseline in Social Cognition (SC) Composite
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Measured: Baseline and Week 16 (1-month follow-up)
Rate of Change From Baseline in Social Cognition (SC) Composite
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Measured: Baseline and Week 16 (1-month follow-up)
Change From Baseline in Social Cognition (SC) Composite
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Measured: Baseline and Week 24 (3-month follow-up)
Rate of Change From Baseline in Social Cognition (SC) Composite
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Measured: Baseline and Week 24 (3-month follow-up)

Secondary outcomes (15)

Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 12 (Endpoint)
Global Functioning will be assessed using the Clinical Global Impressions-Improvement (CGI-I) Scale. A study physician followed standard CGI protocols to evaluate global improvement at each time point based on all available sources of information (e.g., caregiver interviews, behavior rating forms). The CGI-I employs a 7-point scale with the lowest score, 1, indicating the best outcome and the highest score, 7, indicating the worst outcome. Participants receiving scores of 1 (very much improved) or 2 (much improved) were considered responders. Participants receiving scores of 5 (minimally worse), 6 (much worse), or 7 (very much worse) were considered non-responders; note, no participant received a score worse than 5 which was used as the cut-off for non-responders. Participants receiving scores of 3 (minimally improved) or 4 (no change) were considered to show no significant change and omitted from the analysis.
Measured: Week 12 (Endpoint)
Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 16 (1-month Follow-up)
Global Functioning will be assessed using the Clinical Global Impressions-Improvement (CGI-I) Scale. A study physician followed standard CGI protocols to evaluate global improvement at each time point based on all available sources of information (e.g., caregiver interviews, behavior rating forms). The CGI-I employs a 7-point scale with the lowest score, 1, indicating the best outcome and the highest score, 7, indicating the worst outcome. Participants receiving scores of 1 (very much improved) or 2 (much improved) were considered responders. Participants receiving scores of 5 (minimally worse), 6 (much worse), or 7 (very much worse) were considered non-responders; note, no participant received a score worse than 5 which was used as the cut-off for non-responders. Participants receiving scores of 3 (minimally improved) or 4 (no change) were considered to show no significant change and omitted from the analysis.
Measured: Week 16 (1-month follow-up)
Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 24 (3-month Follow-up)
Global Functioning will be assessed using the Clinical Global Impressions-Improvement (CGI-I) Scale. A study physician followed standard CGI protocols to evaluate global improvement at each time point based on all available sources of information (e.g., caregiver interviews, behavior rating forms). The CGI-I employs a 7-point scale with the lowest score, 1, indicating the best outcome and the highest score, 7, indicating the worst outcome. Participants receiving scores of 1 (very much improved) or 2 (much improved) were considered responders. Participants receiving scores of 5 (minimally worse), 6 (much worse), or 7 (very much worse) were considered non-responders; note, no participant received a score worse than 5 which was used as the cut-off for non-responders . Participants receiving scores of 3 (minimally improved) or 4 (no change) were considered to show no significant change and omitted from the analysis.
Measured: Week 24 (3-month follow-up)
Change From Baseline in Social Functioning (SRS-2)
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Measured: Baseline and Week 12 (Endpoint)
Rate of Change From Baseline in Social Functioning (SRS-2)
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Measured: Baseline and Week 12 (Endpoint)
Change From Baseline in Social Functioning (SRS-2)
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Measured: Baseline and Week 16 (1-month follow-up)
Rate of Change From Baseline in Social Functioning (SRS-2)
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Measured: Baseline and Week 16 (1-month follow-up)
Change From Baseline in Social Functioning (SRS-2)
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Measured: Baseline and Week 24 (3-month follow-up)
Rate of Change From Baseline in Social Functioning (SRS-2)
The change from baseline in the Social Responsiveness Scale (SRS-2) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The SRS-2 is a caregiver reported measure of social behavior in the general population (3-18 yo) used to assess social functioning. The SRS-2 contains 65 items rated on a 4-point scale (1/not true to 4/almost always true). Scores are recoded 0-3 and totaled for a raw score. Raw scores are converted to T-scores based on age and sex. T-scores have a population mean of 50 with a standard deviation of 10. T-scores 60-65 indicate mild social impairment, 66-75 moderate deficits, and above 76 severe deficits strongly associated with autism. Higher SRS-2 T-scores indicate greater severity of social impairment. Larger, negative slopes reflect a greater reduction in severity.
Measured: Baseline and Week 24 (3-month follow-up)
Change From Baseline in Quality of Life (CGSQ)
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Measured: Baseline and Week 12 (Endpoint)
Rate of Change From Baseline in Quality of Life (CGSQ)
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Measured: Baseline and Week 12 (Endpoint)
Change From Baseline in Quality of Life (CGSQ)
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Measured: Baseline and Week 16 (1-month follow-up)
Rate of Change From Baseline in Quality of Life (CGSQ)
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Measured: Baseline and Week 16 (1-month follow-up)
Change From Baseline in Quality of Life (CGSQ)
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Measured: Baseline and Week 24 (3-month follow-up)
Rate of Change From Baseline in Quality of Life (CGSQ)
The change from baseline in the Caregiver Strain Questionnaire (CGSQ) is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. The CGSQ was used to assess quality of life. The CGSQ is a parent-rated questionnaire designed for parents of children and adolescents with emotional and behavioral disorders. It includes 21 items rated on a 5-point problem scale (1 = not at all to 5 = very much) rating subjective internal, subjective external, and objective strain. A global measure of strain can be calculated by averaging the scores together. Higher CGSQ scores indicate greater strain. Larger, negative slopes reflect a greater reduction in strain (i.e., improvement in score).
Measured: Baseline and Week 24 (3-month follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 2016Sep 2021

First posted29 Sep 2016 (estimated)
Study start15 Jun 2016
Primary completionSep 2021
Study completionSep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02918864
Sponsor's protocol ID: 14062403
Acronym: ION-ASD
Status last verified: Apr 2024
First submitted: 9 Sep 2016
Last updated: 5 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Data from this study may be submitted to the National Database for Autism Research (NDAR), a computer system run by the National Institutes of Health that allows researchers studying autism to collect and share information. Data will be shared with study collaborators as well.

Publications

Soorya LV, Siper PM, Beck T, Soffes S, Halpern D, Gorenstein M, Kolevzon A, Buxbaum J, Wang AT. Randomized comparative trial of a social cognitive skills group for children with autism spectrum disorder. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):208-216.e1. doi: 10.1016/j.jaac.2014.12.005. Epub 2014 Dec 20.
PubMed 25721186

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Autism Spectrum Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrated Oxytocin and Nonverbal, Emotion Recognition, and Theory of Mind Training for Children With Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT02918864
Acronym / sponsor ID: ION-ASD / 14062403
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder, Oxytocin, Social Skills, Social cognitive skills, Cognitive Behavioral Intervention, Combination treatment, Syntocinon, NETT (Nonverbal communication, Emotion recognition, Theory of mind Training)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Collaborators: University of Illinois Chicago, University of Chicago, Northwestern University, Eotvos Lorand University
Study start: 15 Jun 2016 (actual)
Primary completion: Sep 2021 (actual)
Study completion: Sep 2021 (actual)
First posted: 29 Sep 2016 (estimated)
Results: Posted 5 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ION-ASD	Experimental	Drug: Oxytocin, Behavioral: Social Cognitive Skills TrainingION-ASD integrates targeted dosing of intranasal oxytocin and social cognitive skills group training curriculum, Seaver-NETT (Nonverbal communication, Emotion recognition, Theory of mind Training).
Facilitated Play	Active comparator	Behavioral: Facilitated Play TherapyThe active comparison condition is a facilitated play therapy group.

Who may qualify

Ages: 8 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Male or female outpatients, 8-11 years of age inclusive
Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for Autism Spectrum Disorder. DSM-V criteria will be established by a clinician with expertise with individuals with ASD. Best estimate Diagnosis will be reached using DSM-5 criteria, the Autism Diagnostic Observation Schedule (ADOS-2) and the Autism Diagnostic Interview (ADI-R), or Autism Screening Interview.
Mean score of 9 or less on mentalizing items of Strange Stories Test (Highest possible score = 12, items 21-25, 27).
Have a Clinician's Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Baseline.
Verbal and performance scale intelligence quotient (IQ) ≥ 80 (both subtests of the Wechsler Intelligence Scale for Children-V (WISC-V) ≥ 70).

Key exclusion criteria (21 listed)

Patients born prior to 35 weeks gestational age.
Patients with a primary psychiatric diagnosis other than ASD.
Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal brain MRI/structural lesion.
Pregnant female patients, sexually active female patients on hormonal birth control and sexually active females who do not use at least two types of non-hormonal birth control.
Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxytocinAlso: SyntocinonThis is an integrated pharmacological-behavioral intervention targeting social cognitive skills for school-aged children with ASD. Four doses of intranasal oxytocin (24 IUs/dose) will be delivered each week before weekly homework and group therapy sessions.	Drug	ION-ASD
Social Cognitive Skills TrainingAlso: NETTSocial cognitive skills training utilize cognitive behavioral strategies such as problem identification, affective education, performance feedback, and weekly homework activities to target impairments in nonverbal synchrony, emotional expression, and interpretation of intent. The NETT curriculum is manualized and anchored in CBI strategies, such as problem identification, affective education, performance feedback, and weekly homework activities. Parent education sessions run concurrently with child groups to help facilitate generalization.	Behavioural	ION-ASD
Facilitated Play TherapyThe facilitated play therapy group is a manualized treatment designed to tailor play to the interests and abilities of group members. Therapists use general therapeutics strategies such as reflective functioning statements to foster communication with therapists as well as between peers. Standard educational practices for children with ASD such as visual supports, schedules, and short-directed statements are also used. The concurrent parent group is supportive in nature.	Behavioural	Facilitated Play

Primary outcome

Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame: Baseline and Week 12 (Endpoint)
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame: Baseline and Week 12 (Endpoint)
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame: Baseline and Week 16 (1-month follow-up)
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame: Baseline and Week 16 (1-month follow-up)
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame: Baseline and Week 24 (3-month follow-up)
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite
Time frame: Baseline and Week 24 (3-month follow-up)
The change from baseline in SBI is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SBI is a composite score based on Soorya et al. (2015) which identified measures that comprise this metric. Scores from the Children's Communication Checklist-2 (CCC-2) Social Relations and Nonverbal Communication subscales and the Griffith Empathy Measure (GEM) were standardized as z-scores using the sample means and standard deviations at baseline. CCC-2 subscale scores and reversed GEM total scores were used so higher z-scores reflect more impairment across measures. The SBI outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SBI z-score equals 0; higher individual scores indicate relatively more impairment in social behavior skills. Larger, negative slopes represent improvement.
Change From Baseline in Social Cognition (SC) Composite
Time frame: Baseline and Week 12 (Endpoint)
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Rate of Change From Baseline in Social Cognition (SC) Composite
Time frame: Baseline and Week 12 (Endpoint)
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Change From Baseline in Social Cognition (SC) Composite
Time frame: Baseline and Week 16 (1-month follow-up)
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Rate of Change From Baseline in Social Cognition (SC) Composite
Time frame: Baseline and Week 16 (1-month follow-up)
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Change From Baseline in Social Cognition (SC) Composite
Time frame: Baseline and Week 24 (3-month follow-up)
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.
Rate of Change From Baseline in Social Cognition (SC) Composite
Time frame: Baseline and Week 24 (3-month follow-up)
The change from baseline in SC is represented by the slope of each group. The primary outcome is the difference between groups in this rate of change or the group*time interaction. SC is a composite score, including the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA2), based on Soorya et al. (2015). RMET has 28 items rated correct/incorrect (total 0-28). DANVA2 contains 4 sets of 24 items rated correct/incorrect (total 0-96). Percent correct was calculated for each measure given the difference in denominators and to allow for administrative omissions. Percentages were standardized as z-scores using the sample means and standard deviations at baseline. The SC outcome was subsequently derived by averaging the z-scores. At baseline, the sample average SC z-score equals 0; higher individual scores reflect stronger skills on social cognitive tasks compared to lower scores. Larger, positive slopes indicate skill improvement.

15 secondary outcomes

Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 12 (Endpoint)
Time frame: Week 12 (Endpoint)
Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 16 (1-month Follow-up)
Time frame: Week 16 (1-month follow-up)
Number of Responder and Non-responder Participants Based on CGI-I Scores at Week 24 (3-month Follow-up)
Time frame: Week 24 (3-month follow-up)
Change From Baseline in Social Functioning (SRS-2)
Time frame: Baseline and Week 12 (Endpoint)
Rate of Change From Baseline in Social Functioning (SRS-2)
Time frame: Baseline and Week 12 (Endpoint)
Change From Baseline in Social Functioning (SRS-2)
Time frame: Baseline and Week 16 (1-month follow-up)
Rate of Change From Baseline in Social Functioning (SRS-2)
Time frame: Baseline and Week 16 (1-month follow-up)
Change From Baseline in Social Functioning (SRS-2)
Time frame: Baseline and Week 24 (3-month follow-up)
Rate of Change From Baseline in Social Functioning (SRS-2)
Time frame: Baseline and Week 24 (3-month follow-up)
Change From Baseline in Quality of Life (CGSQ)
Time frame: Baseline and Week 12 (Endpoint)
Rate of Change From Baseline in Quality of Life (CGSQ)
Time frame: Baseline and Week 12 (Endpoint)
Change From Baseline in Quality of Life (CGSQ)
Time frame: Baseline and Week 16 (1-month follow-up)
Rate of Change From Baseline in Quality of Life (CGSQ)
Time frame: Baseline and Week 16 (1-month follow-up)
Change From Baseline in Quality of Life (CGSQ)
Time frame: Baseline and Week 24 (3-month follow-up)
Rate of Change From Baseline in Quality of Life (CGSQ)
Time frame: Baseline and Week 24 (3-month follow-up)

Results and safety

Results posted to the registry on 5 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ION-ASD	20	16
Facilitated Play	20	17

Primary outcome: Change From Baseline in Social Behavior Impairment (SBI) Composite

Time frame: Baseline and Week 12 (Endpoint). Mean (Standard Error). Unit: z-score

Measure	ION-ASD n = 20	Facilitated Play n = 20
Estimated mean (baseline)	0.12 (0.14)	-0.14 (0.14)
Estimated mean (week 12)	-0.26 (0.14)	-0.16 (0.14)

ION-ASD vs Facilitated Play: Beta Coefficient: -.22, p = 0.037, Mixed Models Analysis

Population analysed: All participants contributed to the intent to treat (ITT) model.

Primary outcome: Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite

Time frame: Baseline and Week 12 (Endpoint). Mean (Standard Error). Unit: scores/week

Measure	ION-ASD n = 20	Facilitated Play n = 20
Value	-0.03 (0.01)	0.00 (0.01)

Population analysed: All participants contributed to the intent to treat (ITT) model.

Primary outcome: Change From Baseline in Social Behavior Impairment (SBI) Composite

Time frame: Baseline and Week 16 (1-month follow-up). Mean (Standard Error). Unit: z-score

Measure	ION-ASD n = 20	Facilitated Play n = 20
Estimated mean (baseline)	0.11 (0.13)	-0.14 (0.14)
Estimated mean (week 16)	-0.29 (0.14)	-0.14 (0.14)

ION-ASD vs Facilitated Play: Beta Coefficient: -.23, p = 0.016, Mixed Models Analysis

Population analysed: All participants contributed to the intent to treat (ITT) model.

Primary outcome: Rate of Change From Baseline in Social Behavior Impairment (SBI) Composite

Time frame: Baseline and Week 16 (1-month follow-up). Mean (Standard Error). Unit: scores/week

Measure	ION-ASD n = 20	Facilitated Play n = 20
Value	-0.03 (0.01)	0.00 (0.01)

Population analysed: All participants contributed to the intent to treat (ITT) model.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ION-ASD	0 of 20 (0%)	20 of 20 (100%)	0 of 20
Facilitated Play	1 of 20 (5%)	20 of 20 (100%)	0 of 20

Limitations and caveats (from the sponsor): Enrollment was slowed down during COVID-19 shut down resulting in the study being under-powered and some groups receiving modified protocols. Apriori secondary analyses of maintenance effects resulted in multiple comparisons tests (i.e., at week 16 and 24) which were not corrected to balance type I/type II errors. Additionally, social cognitive stimuli were not counterbalanced; thus, it's unclear whether social cognitive improvements across groups reflect learning or practice effects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25721186Soorya LV, Siper PM, Beck T, Soffes S, Halpern D, Gorenstein M, Kolevzon A, Buxbaum J, Wang AT. Randomized comparative trial of a social cognitive skills group for children with autism spectrum disorder. J Am Acad Child Adolesc Psychiatry. 2015 Mar;54(3):208-216.e1. doi: 10.1016/j.jaac.2014.12.005. Epub 2014 Dec 20.
Individual participant dataSharing planned: Yes. Data from this study may be submitted to the National Database for Autism Research (NDAR), a computer system run by the National Institutes of Health that allows researchers studying autism to collect and share information. Data will be shared with study collaborators as well.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Latha Soorya, PhD, BCBA principal investigator

Rush University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Social Behavior Impairment (SBI) Composite (time frame: Baseline and Week 12 (Endpoint)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02918864, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.